Dilation instrument with malleable guide and dilation catheter with integral position sensor

ABSTRACT

An apparatus includes a handle assembly, a guide tube, and a dilation catheter. The guide tube extends distally from the handle assembly. At least a distal portion of the guide tube is malleable. The dilation catheter is slidably positioned in the guide tube. The dilation catheter includes a distal end, a dilator, and a position sensor. The position sensor is configured to generate a signal indicating a position of the position sensor in three-dimensional space. The dilation catheter is configured to translate relative to the guide tube.

PRIORITY

This application claims priority to U.S. Provisional Pat. App. No.62/741,614, entitled “Dilation Instrument with Malleable Guide andDilation Catheter with Integral Position Sensor,” filed Oct. 5, 2018,the disclosure of which is incorporated by reference herein.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guide wire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, now abandoned, the disclosureof which is incorporated by reference herein. An example of such asystem is the Relieva® Spin Balloon Sinuplasty™ System by Acclarent,Inc. of Irvine, Calif.

In the context of Eustachian tube dilation, a dilation catheter or otherdilation instrument may be inserted into the Eustachian tube and then beinflated or otherwise expanded to thereby dilate the Eustachian tube.The dilated Eustachian tube may provide improved ventilation from thenasopharynx to the middle ear and further provide improved drainage fromthe middle ear to the nasopharynx. Methods and devices for dilating theEustachian tube are disclosed in U.S. Patent Pub. No. 2010/0274188,entitled “Method and System for Treating Target Tissue within the ET,”published on Oct. 28, 2010, now abandoned, the disclosure of which isincorporated by reference herein; and U.S. Patent Pub. No. 2013/0274715,entitled “Method and System for Eustachian Tube Dilation,” published onOct. 17, 2013, now abandoned, the disclosure of which is incorporated byreference herein. An example of such a system is the Aera® EustachianTube Balloon Dilation System by Acclarent, Inc. of Irvine, Calif.

Image-guided surgery (IGS) is a technique where a computer is used toobtain a real-time correlation of the location of an instrument that hasbeen inserted into a patient's body to a set of preoperatively obtainedimages (e.g., a CT or MRI scan, 3-D map, etc.), such that the computersystem may superimpose the current location of the instrument on thepreoperatively obtained images. An example of an electromagnetic IGSnavigation systems that may be used in IGS procedures is the CARTO® 3System by Biosense-Webster, Inc., of Irvine, Calif. In some IGSprocedures, a digital tomographic scan (e.g., CT or MM, 3-D map, etc.)of the operative field is obtained prior to surgery. A speciallyprogrammed computer is then used to convert the digital tomographic scandata into a digital map. During surgery, special instruments havingsensors (e.g., electromagnetic coils that emit electromagnetic fieldsand/or are responsive to externally generated electromagnetic fields)are used to perform the procedure while the sensors send data to thecomputer indicating the current position of each surgical instrument.The computer correlates the data it receives from the sensors with thedigital map that was created from the preoperative tomographic scan. Thetomographic scan images are displayed on a video monitor along with anindicator (e.g., crosshairs or an illuminated dot, etc.) showing thereal-time position of each surgical instrument relative to theanatomical structures shown in the scan images. The surgeon is thus ableto know the precise position of each sensor-equipped instrument byviewing the video monitor even if the surgeon is unable to directlyvisualize the instrument itself at its current location within the body.

While several systems and methods have been made and used in surgicalprocedures, it is believed that no one prior to the inventors has madeor used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a schematic view of an exemplary surgery navigationsystem being used on a patient seated in an exemplary medical procedurechair;

FIG. 2 depicts a perspective view of an exemplary dilation instrument;

FIG. 3A depicts a side elevational view of the dilation instrument ofFIG. 2 , with a dilation catheter in a retracted position;

FIG. 3B depicts a side elevational view of the dilation instrument ofFIG. 2 , with a dilation catheter in an advanced position, and with adilator of the dilation catheter in a non-expanded state;

FIG. 3C depicts a side elevational view of the dilation instrument ofFIG. 2 , with the dilation catheter in the advanced position, and withthe dilator in an expanded state;

FIG. 4A depicts an enlarged side elevational view of a distal portion ofthe dilation catheter of FIG. 3A, with the dilator in the non-expandedstate;

FIG. 4B depicts an enlarged side elevational view of the distal portionof the dilation catheter of FIG. 4A, with the dilator in the expandedstate;

FIG. 5 depicts an enlarged side elevational view of a distal portion ofa guide tube of the dilation instrument of FIG. 2 in a bent state; and

FIG. 6 depicts an end view of the distal end of the dilation catheter ofFIG. 3A disposed in the guide tube of FIG. 5 .

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose skilled in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. EXEMPLARY IMAGE GUIDED SURGERY NAVIGATION SYSTEM

When performing a medical procedure within a head (H) of a patient (P),it may be desirable to have information regarding the position of aninstrument within the head (H) of the patient (P), particularly when theinstrument is in a location where it is difficult or impossible toobtain an endoscopic view of a working element of the instrument withinthe head (H) of the patient (P). FIG. 1 shows an exemplary IGSnavigation system (10) enabling an ENT procedure to be performed usingimage guidance. In addition to or in lieu of having the components andoperability described herein IGS navigation system (10) may beconstructed and operable in accordance with at least some of theteachings of U.S. Pat. No. 7,720,521, entitled “Methods and Devices forPerforming Procedures within the Ear, Nose, Throat and ParanasalSinuses,” issued May 18, 2010, the disclosure of which is incorporatedby reference herein; and U.S. Pat. Pub. No. 2014/0364725, entitled“Systems and Methods for Performing Image Guided Procedures within theEar, Nose, Throat and Paranasal Sinuses,” published Dec. 11, 2014, nowabandoned, the disclosure of which is incorporated by reference herein.

IGS navigation system (10) of the present example comprises a fieldgenerator assembly (20), which comprises set of magnetic fieldgenerators (24) that are integrated into a horseshoe-shaped frame (22).Field generators (24) are operable to generate alternating magneticfields of different frequencies around the head (H) of the patient (P).A navigation guidewire (40) is inserted into the head (H) of the patient(P) in this example. Navigation guidewire (40) may be a standalonedevice or may be positioned on an end effector or other location of amedical instrument such as a surgical cutting instrument or dilationinstrument. In the present example, frame (22) is mounted to a chair(30), with the patient (P) being seated in the chair (30) such thatframe (22) is located adjacent to the head (H) of the patient (P). Byway of example only, chair (30) and/or field generator assembly (20) maybe configured and operable in accordance with at least some of theteachings of U.S. patent application Ser. No. 15/933,737, entitled“Apparatus to Secure Field Generating Device to Chair,” filed Mar. 23,2018, issued as U.S. Pat. No. 10,561,370 on Feb. 18, 2020, thedisclosure of which is incorporated by reference herein.

IGS navigation system (10) of the present example further comprises aprocessor (12), which controls field generators (24) and other elementsof IGS navigation system (10). For instance, processor (12) is operableto drive field generators (24) to generate alternating electromagneticfields; and process signals from navigation guidewire (40) to determinethe location of a sensor in navigation guidewire (40) within the head(H) of the patient (P). Processor (12) comprises a processing unitcommunicating with one or more memories. Processor (12) of the presentexample is mounted in a console (18), which comprises operating controls(14) that include a keypad and/or a pointing device such as a mouse ortrackball. A physician uses operating controls (14) to interact withprocessor (12) while performing the surgical procedure.

Navigation guidewire (40) includes a sensor (not shown) that isresponsive to positioning within the alternating magnetic fieldsgenerated by field generators (24). A coupling unit (42) is secured tothe proximal end of navigation guidewire (40) and is configured toprovide communication of data and other signals between console (18) andnavigation guidewire (40). Coupling unit (42) may provide wired orwireless communication of data and other signals.

In the present example, the sensor of navigation guidewire (40)comprises at least one coil at the distal end of navigation guidewire(40). When such a coil is positioned within an alternatingelectromagnetic field generated by field generators (24), thealternating magnetic field may generate electrical current in the coil,and this electrical current may be communicated along the electricalconduit(s) in navigation guidewire (40) and further to processor (12)via coupling unit (42). This phenomenon may enable IGS navigation system(10) to determine the location of the distal end of navigation guidewire(40) or other medical instrument (e.g., dilation instrument, surgicalcutting instrument, etc.) within a three-dimensional space (i.e., withinthe head (H) of the patient (P), etc.). To accomplish this, processor(12) executes an algorithm to calculate location coordinates of thedistal end of navigation guidewire (40) from the position relatedsignals of the coil(s) in navigation guidewire (40). While the positionsensor is located in guidewire (40) in this example, such a positionsensor may be integrated into various other kinds of instruments,including those described in greater detail below.

Processor (12) uses software stored in a memory of processor (12) tocalibrate and operate IGS navigation system (10). Such operationincludes driving field generators (24), processing data from navigationguidewire (40), processing data from operating controls (14), anddriving display screen (16). In some implementations, operation may alsoinclude monitoring and enforcement of one or more safety features orfunctions of IGS navigation system (10). Processor (12) is furtheroperable to provide video in real time via display screen (16), showingthe position of the distal end of navigation guidewire (40) in relationto a video camera image of the patient's head (H), a CT scan image ofthe patient's head (H), and/or a computer generated three-dimensionalmodel of the anatomy within and adjacent to the patient's nasal cavity.Display screen (16) may display such images simultaneously and/orsuperimposed on each other during the surgical procedure. Such displayedimages may also include graphical representations of instruments thatare inserted in the patient's head (H), such as navigation guidewire(40), such that the operator may view the virtual rendering of theinstrument at its actual location in real time. By way of example only,display screen (16) may provide images in accordance with at least someof the teachings of U.S. Pub. No. 2016/0008083, entitled “GuidewireNavigation for Sinuplasty,” published Jan. 14, 2016, issued as U.S. Pat.No. 10,463,242 on Nov. 5, 2019, the disclosure of which is incorporatedby reference herein. In the event that the operator is also using anendoscope, the endoscopic image may also be provided on display screen(16).

The images provided through display screen (16) may help guide theoperator in maneuvering and otherwise manipulating instruments withinthe patient's head (H) when such instruments incorporate navigationguidewire (40). It should also be understood that other components of asurgical instrument and other kinds of surgical instruments, asdescribed below, may incorporate a sensor like the sensor of navigationguidewire (40).

II. EXEMPLARY DILATION INSTRUMENT WITH MALLEABLE GUIDE AND DILATIONCATHETER WITH INTEGRAL SENSOR

As noted above, it may be desirable to use an instrument to dilate oneor more anatomical passageways within a head of a patient, including butnot limited to a Eustachian tube, an ostium of a paranasal sinus, orother passageways associated with drainage of a paranasal sinus. Eachanatomical passageway may require an entry angle that is uniquelyassociated with that particular anatomical passageway. For instance,entry of a dilation catheter into a maxillary sinus ostium may requirean angle of entry that differs from the angle of entry required forentry of a dilation catheter into a frontal recess of a frontal sinus.It may therefore be desirable to provide an instrument guide featurethat is malleable, thereby enabling the operator to adjust the dilationinstrument based on the needs at hand. Malleability of an instrumentguide feature may also allow the operator to dilate differentpassageways at different entry angles within the same medical procedure,such that the operator may bend the guide feature between dilations toachieve different exit angles. Examples of dilation instruments withmalleable guide features are disclosed in U.S. Pub. No. 2012/0071857,entitled “Methods and Apparatus for Treating Disorders of the Sinuses,”published Mar. 22, 2012, now abandoned, the disclosure of which isincorporated by reference herein; U.S. Pub. No. 2017/0120020, entitled“Apparatus for Bending Malleable Guide of Surgical Instrument,”published May 4, 2017, issued as U.S. Pat. No. 10,137,286 on Nov. 27,2018, the disclosure of which is incorporated by reference herein; andU.S. patent application Ser. No. 15/822,489, entitled “Guide Catheterfor Dilation System,” filed Nov. 27, 2017, now abandoned, the disclosureof which is incorporated by reference herein.

In addition to providing malleability in a guide feature of a dilationinstrument, it may also be desirable to incorporate one or more positionsensors into the dilation instrument, to provide compatibility with IGSnavigation system (10). As noted above, this may be accomplished byincorporating a position sensor in a guidewire (40) that is used withthe dilation instrument. In some instances, it may be desirable to use adilation instrument without using a guidewire (40). In some suchinstances, a position sensor may be integrated into some other componentof the dilation instrument, such as a dilation catheter. Examples ofdilation catheters that incorporate a position sensor are described inU.S. patent application Ser. No. 15/797,049, entitled “Dilation Catheterwith Navigation Sensor and Vent Passageway in Tip,” filed Oct. 30, 2017,issued as U.S. Pat. No. 10,736,647 on Aug. 11, 2020, the disclosure ofwhich is incorporated by reference herein; and U.S. patent applicationSer. No. 15/830,205, entitled “Dilation Instrument with Navigation andDistally Located Force Sensor,” filed Dec. 4, 2017, issued as U.S. Pat.No. 10,864,046 on Dec. 15, 2020, the disclosure of which is incorporatedby reference herein.

It may further be desirable to provide a dilation instrument thatincludes both a malleable guide feature and a position sensor that isintegral with a dilation catheter, without requiring an additionalguidewire. The malleability and position sensing may provide thebenefits noted above; while omission of a guidewire may reduce the costand complexity of the instrument. An example of such an instrument isdescribed in greater detail below.

FIGS. 2-3C show an exemplary dilation instrument (100) that includes ahandle assembly (110), a guide tube (130) extending distally from handleassembly (110), and a dilation catheter (150) that is slidably disposedin guide tube (130). Dilation catheter (150) is coupled with a slider(120) of handle assembly (110). Slider (120) is operable to translatelongitudinally along a slot (112) of handle assembly (110) to therebydrive dilation catheter (150) between a proximal position (FIG. 3A) anda distal position (FIGS. 3B-3C). Various suitable ways in which slider(120) and dilation catheter (150) may be coupled will be apparent tothose skilled in the art in view of the teachings herein.

Handle assembly (110) of the present example further includes aninflation port (114). Inflation port (114) may comprise a conventionalluer fitting or any other suitable kind of structure. Inflation port(114) is in fluid communication with a dilator (156) of dilationcatheter (150). Dilator (156) will be described in greater detail below.Various suitable ways in which inflation port (114) may be coupled withdilator (156) will be apparent to those skilled in the art in view ofthe teachings herein. Inflation port (114) is further configured tocouple with a conduit (106), which is further coupled with a fluidsource (50). Fluid source (50) is configured to provide inflation fluid(e.g., saline, etc.) to dilator (156) via conduit (106) and inflationport (114). By way of example only, fluid source (50) may be configuredand operable in accordance with at least some of the teachings of U.S.Pat. No. 9,962,530, entitled “Inflator for Dilation of AnatomicalPassageway,” issued May 8, 2018, the disclosure of which is incorporatedby reference herein.

Handle assembly (110) of the present example further includes a cableport (116), which is coupled with a cable (102). Cable port (116) isfurther in communication with a position sensor (158) of dilationcatheter (150). Position sensor (158) will be described in greaterdetail below. Various suitable ways in which cable port (116) may becoupled with position sensor (158) will be apparent to those skilled inthe art in view of the teachings herein. Cable (102) leads to a plug(104), which is configured to couple with processor (12) of IGSnavigation system (10). Cable port (116), cable (102), and plug (104)thus provide a pathway for communication of position-indicative signalsfrom position sensor (158) to processor (12), thereby enabling processor(12) to determine the position of sensor (158) in three-dimensionalspace. By way of example only, plug (104) may couple with processor (12)via a conventional USB coupling or in any other suitable fashion. Asanother merely illustrative example, instrument (100) may providewireless communication of position-indicative signals from positionsensor (158) to processor (12).

As best seen in FIGS. 4A-4B, dilation catheter (150) of the presentexample includes a shaft (152) with a distal end (154), a dilator (156)that is proximal to distal end (154), and a position sensor (158) thatis longitudinally interposed between dilator (156) and distal end (154).Dilator (156) of the present example comprises a balloon that isconfigured to transition between the non-expanded state (FIG. 4A) andthe expanded state (FIG. 4B) based on communication of fluid from and tofluid source (50). In the non-expanded state, dilator (156) isconfigured to fit within anatomical passageways such as a Eustachiantube, an ostium of a paranasal sinus, and other passageways associatedwith drainage of a paranasal sinus. In the expanded state, dilator (156)is configured to dilate such a passageway.

Position sensor (158) of the present example comprises a wire coil thatis wrapped about the central longitudinal axis of catheter shaft (152).When position sensor (158) is positioned within an alternatingelectromagnetic field generated by field generators (24), thealternating magnetic field may generate electrical current in positionsensor (158), and this electrical current may be communicated along anelectrical conduit dilation catheter (150) and further to processor (12)via cable port (116), cable (102), and plug (104). This phenomenon mayenable IGS navigation system (10) to determine the location of distalend (154) of dilation catheter (150) within a three-dimensional space(i.e., within the head (H) of the patient (P), etc.). To accomplishthis, processor (12) executes an algorithm to calculate locationcoordinates of the distal end (154) of dilation catheter (150) from theposition related signals of the position sensor (158) in dilationcatheter (150).

In the present example, when dilation catheter (150) is in the retractedposition as shown in FIG. 3A, distal end (154) of dilation catheter(150) is at substantially the same longitudinal position as distal end(132) of guide tube (130). Thus, the signals from position sensor (158)will effectively convey the position of distal end (132) of guide tube(130) when dilation catheter (150) is in the retracted position as shownin FIG. 3A, even if guide tube (130) is in a bent state as described ingreater detail below. The operator may thus rely on feedback from IGSnavigation system (10) when navigating distal end (132) of guide tube(130) to the appropriate position in the head (H) of the patient (P)while dilation catheter (150) is in the retracted position.

Once distal end (132) of guide tube (130) has reached the appropriateposition in the head (H) of the patient (P), and the operator hasobserved this positioning via IGS navigation system (10), the operatormay advance slider (120) along slot (122) to advance dilation catheter(150) relative to guide tube (130) to the advanced position shown inFIG. 3B. Since position sensor (158) is integral with dilation catheter(150), position sensor (158) will also be advanced, thereby providing asignal indicating the location of distal end (154) in the head (H) ofthe patient (P). The operator may again consult IGS navigation system(10) to observe whether distal end (154) of dilation catheter (150) isat an appropriate position in the head (H) of the patient (P), which mayfurther indicate that dilator (156) is properly located in the targetedanatomical passageway. Once distal end (154) of dilation catheter (154)has reached the appropriate position in the head (H) of the patient (P),and the operator has observed this positioning via IGS navigation system(10), the operator may actuate fluid source (50) to inflate dilator(156) as shown in FIG. 3C and thereby dilate the targeted anatomicalpassageway.

Guide tube (130) of the present example is formed of a malleablematerial such as metal. The operator may thus bend guide tube (130) fromthe straight configuration shown in FIGS. 1-3C to a bent configurationon an ad hoc basis in order to facilitate access to the targetedanatomical passageway. By way of example only, guide tube (130) may beformed of a stainless steel hypotube. FIG. 5 shows an exemplary bentform of guide tube (130), where a bend (134) has been provided justproximal to distal end (132). Various suitable bend angles associatedwith various potentially targeted anatomical passageways will beapparent to those skilled in the art in view of the teachings herein.Guide tube (130) is configured to maintain bend (134) during normal useof instrument (100), including when dilation catheter (150) translatesrelative to guide tube (130).

In some scenarios, a separate bending instrument may be used toprecisely and reliably form bend (134). An example of such an instrumentis described in U.S. Pub. No. 2017/0120020, entitled “Apparatus forBending Malleable Guide of Surgical Instrument,” published May 4, 2017,issued as U.S. Pat. No. 10,137,286 on Nov. 27, 2018, the disclosure ofwhich is incorporated by reference herein. As noted above, sinceposition sensor (158) is effectively positioned at distal end (132) ofguide tube (130) when dilation catheter (150) is in the retractedposition, signals from position sensor (158) will effectively indicatethe position of distal end (132) in three-dimensional space whendilation catheter (150) is in the retracted position.

In some versions, guide tube (130) defines an inner diameter that issubstantially larger than the outer diameter of dilation catheter (150),such that a substantial gap is defined between the outer diameter ofdilation catheter (150) and the inner diameter of guide tube (130). Thismay allow instrument (10) to provide suction, irrigation, or otherfunctionality through the gap. Moreover, some such versions may havedilation catheter (150) positioned such that the central longitudinalaxis of dilation catheter (150) is laterally offset from the centrallongitudinal axis of guide tube (130). In other words, by positioningdilation catheter (150) non-coaxially relative to guide tube (130), thegap defined between the outer diameter of dilation catheter (150) andthe inner diameter of guide tube (130) may be more easily used toposition other features. FIG. 6 shows an example of such an arrangement,where dilation catheter (150) is non-coaxially positioned relative toguide tube (130), and with a substantial gap (136) defined between theouter diameter of dilation catheter (150) and the inner diameter ofguide tube (130) may be more easily used to position other features. Byway of example only, an irrigation device, suction device, ablationdevice, or other device may be positioned in gap (136).

III. EXEMPLARY COMBINATIONS

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

An apparatus comprising: (a) a handle assembly; (b) a guide tubeextending distally from the handle assembly, wherein at least a distalportion of the guide tube is malleable; and (c) a dilation catheterslidably positioned in the guide tube, wherein the dilation catheterincludes: (i) a distal end, (ii) a dilator, and (iii) a position sensor,wherein the position sensor is configured to generate a signalindicating a position of the position sensor in three-dimensional space,wherein the dilation catheter is configured to translate relative to theguide tube.

Example 2

The apparatus of Example 1, wherein the handle assembly includes aninflation port, wherein the inflation port is configured to couple thedilator with an external fluid source.

Example 3

The apparatus of Example 2, further comprising a fluid source in fluidcommunication with the inflation port, wherein the dilator is configuredto receive fluid from the fluid source to thereby transition from anon-expanded state to an expanded state.

Example 4

The apparatus of any one or more of Examples 1 through 3, wherein thehandle assembly further includes a data port, wherein the data port isconfigured to couple the position sensor with an external image guidedsurgery system.

Example 5

The apparatus of Example 4, wherein the data port comprises a cableport, wherein the data port is configured to couple the position sensorwith an external image guided surgery system via a cable.

Example 6

The apparatus of any one or more of Examples 1 through 5, the handleassembly further comprising a slider coupled with the dilation catheter,wherein the slider is operable to drive the dilation catheter relativeto the handle assembly between a retracted position and an advancedposition.

Example 7

The apparatus of Example 6, wherein the dilation catheter has a distalend, wherein the distal end of the dilation catheter is configured to bepositioned at or proximal to a distal end of the guide tube when thedilation catheter is in the retracted position.

Example 8

The apparatus of any one or more of Examples 6 through 7, wherein thedistal end of the dilation catheter is configured to be positioneddistal to a distal end of the guide tube when the dilation catheter isin the advanced position.

Example 9

The apparatus of any one or more of Examples 1 through 8, wherein theguide tube comprises a hypotube.

Example 10

The apparatus of any one or more of Examples 1 through 9, wherein theguide tube defines an inner diameter, wherein the dilation catheterdefines an outer diameter, wherein the guide tube and the dilationcatheter cooperate to define a gap between the inner diameter of theguide tube and the outer diameter of the dilation catheter.

Example 11

The apparatus of Example 10, wherein the gap is sized to providecommunication of one or more of: (i) suction through the gap, (ii)irrigation fluid through the gap, or (iii) another instrument throughthe gap.

Example 12

The apparatus of any one or more of Examples 10 through 11, wherein theguide tube defines a first central longitudinal axis, wherein thedilation catheter defines a second central longitudinal axis, whereinthe second central longitudinal axis is laterally offset from the firstcentral longitudinal axis.

Example 13

The apparatus of any one or more of Examples 1 through 12, wherein theposition sensor is longitudinally interposed between the distal end ofthe dilation catheter and the dilator.

Example 14

The apparatus of any one or more of Examples 1 through 13, wherein theposition sensor comprises a wire coil positioned coaxially about acentral longitudinal axis of the dilation catheter.

Example 15

The apparatus of any one or more of Examples 1 through 14, wherein thedilator comprises a balloon.

Example 16

An apparatus, comprising: (a) a dilation instrument, the dilationinstrument comprising: (i) a guide tube having a malleable distalportion, and (ii) a dilation catheter slidably positioned in the guidetube, wherein the dilation catheter is configured to translate relativeto the guide tube, wherein the dilation catheter includes: (A) a distalend, (B) a dilator, and (C) a position sensor; (b) a fluid source influid communication with the dilator; and (c) an image guided surgerysystem in communication with the position sensor, wherein the imageguided surgery system is configured to determine a position of theposition sensor in three-dimensional space based on signals generated bythe position sensor.

Example 17

The apparatus of Example 17, wherein the image guided surgery system isfurther configured to determine a position of a distal end of the guidetube in three-dimensional space based on signals generated by theposition sensor when the dilation catheter is in a retracted positionrelative to the guide tube.

Example 18

The apparatus of any one or more of Examples 16 through 17, furthercomprising a handle, wherein the guide tube extends distally from thehandle.

Example 19

The apparatus of Example 18, wherein the fluid source is remote from thehandle, wherein the handle is coupled with the fluid source via aconduit.

Example 20

An apparatus comprising: (a) a handle assembly, the handle assemblyincluding: (i) a slider, (ii) a fluid port, and (iii) a data port; (b) aguide tube extending distally from the handle assembly, wherein at leasta distal portion of the guide tube is malleable; and (c) a dilationcatheter slidably positioned in the guide tube, wherein the dilationcatheter is coupled with the slider, wherein the slider is operable totranslate the dilation catheter relative to the guide tube, wherein thedilation catheter includes: (i) a distal end, (ii) a dilator in fluidcommunication with the fluid port, and (iii) a position sensor incommunication with the data port, wherein the position sensor isconfigured to generate a signal indicating a position of the positionsensor in three-dimensional space.

IV. MISCELLANEOUS

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those skilled in the art in view of the teachingsherein. Such modifications and variations are intended to be includedwithin the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one skilled in the artwithout departing from the scope of the present invention. Several ofsuch potential modifications have been mentioned, and others will beapparent to those skilled in the art. For instance, the examples,versions, geometrics, materials, dimensions, ratios, steps, and the likediscussed above are illustrative and are not required. Accordingly, thescope of the present invention should be considered in terms of thefollowing claims and is understood not to be limited to the details ofstructure and operation shown and described in the specification anddrawings.

We claim:
 1. An apparatus comprising: (a) a handle assembly including:(i) an inflation port, (ii) a data port, the data port comprising acable port, and (iii) a slider; (b) a guide tube extending distally fromthe handle assembly, the guide tube having a distal end, at least adistal portion of the guide tube comprising a malleable stainless steelhypotube, the guide tube defining a first central longitudinal axis; and(c) a dilation catheter coupled with the slider and slidably positionedin the guide tube, the dilation catheter defining a second centrallongitudinal axis, the second central longitudinal axis being laterallyoffset from the first central longitudinal axis of the guide tube, theslider being operable to drive the dilation catheter longitudinallyrelative to the handle assembly between a retracted position and anadvanced position, the dilation catheter including: (i) a distal endconfigured to be positioned at or proximal to the distal end of theguide tube when the dilation catheter is in the retracted position, thedistal end of the dilation catheter being further configured to bepositioned distal to the distal end of the guide tube when the dilationcatheter is in the advanced position, (ii) a dilator comprising aballoon, the inflation port being configured to couple the dilator withan external fluid source, and (iii) a position sensor, the positionsensor being configured to generate a signal indicating a position ofthe position sensor in three-dimensional space, the position sensorbeing longitudinally interposed between the distal end of the dilationcatheter and the dilator, the position sensor comprising a wire coilpositioned coaxially about the second central longitudinal axis, thedata port being further configured to couple the position sensor with anexternal image guided surgery system via a cable coupled with the cableport, the dilation catheter being configured to translate relative tothe guide tube, the guide tube defining an inner diameter, the dilationcatheter defining an outer diameter, the guide tube and the dilationcatheter cooperating to define a gap between the inner diameter of theguide tube and the outer diameter of the dilation catheter, and the gapbeing sized to provide: (A) a fluid path for an irrigation devicethrough the gap, (B) a fluid path for a suction device through the gap,and (C) advancement of a guidewire along the gap, the gap being sized toprovide advancement of the guidewire along the gap, the guidewire beingpositioned lateral to the dilation catheter.
 2. The apparatus of claim1, further comprising a fluid source in fluid communication with theinflation port, the dilator being configured to receive fluid from thefluid source to thereby transition from a non-expanded state to anexpanded state.
 3. The apparatus of claim 1, a proximal portion of theguide tube comprising the malleable stainless steel hypotube, themalleable stainless steel hypotube extending to the handle, the distalportion of the guide tube being configured to be bent by a separatebending instrument and to thereafter maintain a bend.
 4. An apparatuscomprising: (a) a handle assembly including a slot, the handle assemblyincluding: (i) a slider configured to longitudinally advance along theslot, (ii) a fluid port, and (iii) a data port; (b) a guide tubeextending distally from the handle assembly, at least a distal portionof the guide tube being malleable stainless steel, the guide tubeincluding an inner surface defining an inner diameter, the guide tubefurther defining a central longitudinal axis; and (c) a dilationcatheter slidably positioned in the guide tube, the dilation catheterbeing coupled with the slider, the slider being operable to translatethe dilation catheter relative to the guide tube, the dilation catheterincluding: (i) a distal end configured to be positioned at or proximalto a distal end of the guide tube when the dilation catheter is in aretracted position and further configured to be positioned distal to thedistal end of the guide tube when the dilation catheter is in anadvanced position, (ii) a dilator in fluid communication with the fluidport, the dilator being configured to transition between a non-expandedstate and an expanded state, the dilator being sized to fit within aEustachian tube when in the non-expanded state and is sized to dilatethe Eustachian tube when in the expanded state, (iii) a position sensorin communication with the data port, the position sensor beingconfigured to generate a signal indicating a position of the positionsensor in three-dimensional space, the position sensor beinglongitudinally interposed between the dilator and the distal end of thedilation catheter, and (iv) a shaft, the shaft defining a centrallongitudinal axis, the central longitudinal axis of the shaft beinglaterally offset from the central longitudinal axis of the guide tube, afirst portion of the shaft being positioned to contact the inner surfaceof the guide tube, a second portion of the shaft defining a gap betweenan outer surface of the second portion of the shaft and the innersurface of the guide tube; the gap being sized to provide: (A) a fluidpath for irrigation fluid through the gap, (B) a fluid path for suctionthrough the gap, and (C) advancement of another instrument along thegap, the distal portion of the guide tube being configured to maintain afirst bend such that each of the dilator, fluid path for irrigation,fluid path for suction, and the other instrument achieves a first exitangle, the distal portion of the guide tube being further configured totransition from the first bend to a second bend such that each of thedilator, fluid path for irrigation, fluid path for suction, and theother instrument achieves a second exit angle, each of the first andsecond bends being angularly offset from the central longitudinal axisof the guide tube, the distal portion of the guide tube being configuredto maintain each of the first and second bends, the first exit anglebeing configured for placement of the dilator during dilation of amaxillary sinus ostium, the second exit angle being configured forplacement of the dilator during dilation of a frontal sinus.